The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act

This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance describes FDA’s current thinking regarding the scope of the provision prohibiting the marketing of a tobacco product in combination with another product regulated under the Federal Food, Drug, and Cosmetic Act (FDCA). It is not intended to be an exhaustive analysis of all activities that may or may not fall within the scope of the prohibition.